510(k) K101855
K101855 is an FDA 510(k) premarket notification submitted by Gen-Probe Prodesse, Inc. for the device "PROFAST+ ASSAY". The FDA issued a decision of Substantially Equivalent on July 23, 2010. The device falls under product code OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification), a Class II device regulated under 21 CFR 866.3332. Gen-Probe Prodesse, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2010
- Date Received
- July 1, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- Device Class
- Class II
- Regulation Number
- 866.3332
- Review Panel
- MI
- Submission Type
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens